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Halozyme Therapeutics Inc
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Good afternoon, everyone. I would now like to turn the conference over to Al Kildani, Vice President of Investor Relations and Corporate Communications for Halozyme Therapeutics. Mr. Kildani, please go ahead.
Good afternoon and welcome to our first quarter 2020 financial results conference call. In addition to our press release issued today after the close, you can find a supplementary slide presentation that will be referenced on today’s call in the Investor Relations section of our website.
Leading the call will be Dr. Helen Torley, Halozyme’s President and Chief Executive Officer, who will provide an update on our business and Elaine Sun, our Chief Financial Officer who will review our financial results for the first quarter 2020.
During the call, we will be making forward-looking statements. I refer you to our SEC filings for a full listing of the risks and uncertainties. I’ll now turn the call over to Helen.
Thank you, Al. And it's really a delight to welcome Elaine to her first call as our Chief Financial Officer at Halozyme. I'd like to open this call by addressing two topics of greatest interest to the Halozyme investors today, one specific to our company and one affecting all companies and those are firstly the recent FDA approval of Janssen's DARZALEX FASPRO utilizing ENHANZE technology and then the impact on our business from the COVID-19 pandemic.
This is our first call since receiving the very exciting news on the 1st of May that Janssen received U.S. FDA approval for the subcutaneous formulation of DARZALEX utilizing our ENHANZE technology which will be commercialized with the brand name DARZALEX FASPRO. This represents one of the most significant events in the history of our company. This approval is for a product utilizing ENHANZE that is both fast growing and a blockbuster drug in its IV form with many years of exclusivity remaining.
The U.S. approval follows on the heels of Janssen’s recent receipt of a positive CHMP opinion for subcutaneous DARZALEX utilizing ENHANZE from the European Medicines Agency which also recommended approval. This event generally means that marketing clearance in Europe is also on the horizon potentially arriving in mid-2020. As you’ll note on Slide 3, DARZALEX FASPRO utilizing ENHANZE technology was granted a broad label covering five of the seven indications for which the IV form is currently approved.
We estimate that this label allows DARZALEX FASPRO utilizing ENHANZE to address the majority of multiple myeloma patients based on our assessment of analyst estimates for how DARZALEX IV is used today.
Importantly, this was the first time the FDA has approved a product utilizing ENHANZE for indications based on single arm studies. We view this as the first demonstration of an approach, the FDA actually alluded to at the ODAC meeting for rituximab in 2017 during which it was stated that it might not be necessary to do large, complex comparative studies for each and every indication when evaluating ENHANZE in combination with an already approved drug.
In this case, Janssen submitted for approval based on two studies. The first is a COLUMBA Phase III study which examined subcutaneous daratumumab with ENHANZE compared to IV daratumumab in about 500 patients. And the second study is a Phase II single arm study called PLEIADES which examined daratumumab SC in three earlier treatment lines in combination with different multiple myeloma treatments.
We believe this is a huge win and very encouraging for the clinical development plans for all of our other ENHANZE collaboration partners. Most importantly, we view this as a terrific advance for patients suffering from multiple myeloma who are currently receiving treatment with IV DARZALEX.
We believe the ability to reduce the administration time from what is often four to six hours down to three to five minutes will offer tremendous convenience to patients and value to the healthcare system. This applies every day but obviously today the healthcare system is strained with the ongoing impact from COVID-19 pandemic and perhaps it's even more valuable at this time.
This brings us to Slide 4 and the second topic of great interest to investors and that is the COVID-19 pandemic. This has obviously created enormous challenges for so many people around the globe. Top of mind for everyone at at Halozyme are those directly impacted by the disease as well as those on the front lines of treating patients.
The Halozyme team is committed to doing our part to helping the community and I could not be prouder of how our employees have joined in this effort. Now despite the challenges posed by COVID-19, I'm pleased to see we’re maintaining our overall progress in our mission of providing patients with disruptive solutions that can lead to better patient experiences and outcomes. Let me now provide you with an update as to where the company stands today operationally and financially during the pandemic.
Halozyme remains in a strong financial position today with our nine partnerships, four products now approved and multiple programs in development. We have a robust diverse business model poised to generate solid growth and earnings. We have a strong balance sheet and we remain confident in our long-term growth outlook. We've taken many measures to protect the health and wellbeing of our workforce. During this pandemic, the health and safety of our employees, their families, and our local communities is our highest priority.
As we began to see the emerging pandemic in February, we assembled the COVID-19 preparedness team to develop a plan for maintaining business continuity, should the situation worsen. In mid-March, we successfully transitioned the majority of our staff to working from home and implemented a limited rotation for the small number of essential onsite employees in anticipation of a shelter-in-place mandates from the State of California. I'm pleased to report that we were able to quickly and successfully transition the majority of our staff to working from home and we've been able to maintain a high level of productivity. In addition to the proactive planning by our business continuity team and the hard work and commitment of our employees, we were able to do this because of the nature of our collaboration driven business model.
And as we think ahead to the time when our workforce returns to the office, our preparedness team has already developed a plan that we will continue to refine based on the national, state and local guidelines. With regard to our business program, I'll now describe what we know today, what we don't yet know as a global community works to fight COVID-19. To-date based on latest partner feedback, we continue to project that the majority of our clinical study starts that we expected in 2020 will still occur in 2020 with delays of between one to two quarters from the original plan date.
We know of one non-milestone bearing clinical trial start that has been delayed as a result of COVID-19 where we do not yet have information on the new target start date and also have two Phase I trials where enrollment has been impacted resulting in an expected longer time to study completion.
Moving to new enhanced deals, we have one of the broadest slates of ongoing discussions with both biotech and pharma companies that we've ever had. We did see some slowing in the pace of discussions in March and April. Based on company feedback, we expect this will revert to the usual pace of conversations in the second quarter.
Let me now move to an update on our supply chain. We're working closely with our contract manufacturers to ensure the safety and reliability of our supply. We're in frequent contact with our CMOs to hear updates and to ensure the integrity of our API supply. Based on this feedback, we currently do not expect an interruption in our ability to supply our API or Hylenex as a result of COVID-19. Our contract manufacturers continue to operate as an essential business during the pandemic and have communicated that they have not identified any significant risk, delay or concern resulting from COVID-19 that may have a substantial effect on delivery of any product.
We'll obviously continue to monitor the operations of our contract manufacturers and their ability to continue to provide us with our products.
Turning now to regulatory, while regulators have curtailed some activities during the pandemic, we're pleased to report that our major initiatives with regulatory agencies around the globe appear to be proceeding at a normal pace.
As examples earlier this month, Janssen received U.S. FDA approval for DARZALEX FASPRO utilizing ENHANZE after submission of its BLA in July of 2019. Janssen also received a positive CHMP opinion for DARZALEX SC utilizing ENHANZE in late April following their July 2019 submission in Europe demonstrating things are on track and we're also pleased to note that Janssen submitted their NDA in Japan for DARZALEX SC utilizing ENHANZE in late April and looking ahead after submitting the BLA with the FDA for the subcutaneous fixed-dose combination of Perjeta/Herceptin utilizing ENHANZE in December of 2019 and action date of October 18, 2020 was assigned.
We're certainly encouraged that the FDA and the EMA remain highly engaged with our partners during the pandemic. So in summary, based on all of the latest updates from our partners and suppliers as well as our planned expenditures, we feel confident maintaining our guidance for 2020 at this time.
It's obviously difficult to predict how the pandemic recovery will unfold in the coming quarters. Therefore, we will continually monitor the situation and provide updates if new information emerges. In summary, despite the challenges posed by COVID-19 pandemic, we've continued to execute very well on our strategy and remain in a strong position to drive future growth for Halozyme.
I'll move now to a deeper update on our key partner programs beginning on Slide 5 with DARZALEX. In its current IV form, DARZALEX generated approximately $3 billion in sales in 2019 and grew approximately 50% globally in the first quarter of 2020 compared to the first quarter of 2019. Analysts currently project sales for DARZALEX franchise of $3.9 billion in 2020 and $7.8 billion in 2024. Janssen has stated that the subcutaneous formulation of DARZALEX utilizing ENHANZE is a core part, all of this future growth strategy supporting their goals of expansion into the frontline setting in addition to treatment in the community setting.
The potential value proposition of daratumumab SC with ENHANZE is strong. With the U.S. approval just granted and EU approval potentially in mid-2020, we're extremely excited about the launch of DARZALEX FASPRO utilizing ENHANZE and what this means for our ENHANZE franchise. We believe DARZALEX FASPRO will provide the strongest validation to date all of the commercial potential over ENHANZE drug delivery technology and after an initial period post-launch during which formulary approvals, EMR orders and reimbursement are established, we expect the uptake of DARZALEX FASPRO with ENHANZE will be robust resulting in strong growth in royalty revenues for Halozyme.
Turning now to Slide 6 and the next product we expect our partners to launch the subcutaneous fixed dose combination of Perjeta and Herceptin utilizing ENHANZE technology which is indicated for patients with early and metastatic HER 2 positive breast cancer, the subcutaneous fixed dose combination of Perjeta and Herceptin is an important first, combining two therapeutic antibodies in a single fixed dose formulation utilizing ENHANZE enabling a five to eight minutes subcutaneous injection compared to 1.5 to 2.5 hour injection at for the sequential IV administration of Herceptin and then Perjeta.
According to Roche’s quarter financial results, Perjeta IV sales experienced 22% global growth driven by continued update in the early breast cancer space. Analysts currently predict $4.1 billion in global sales in 2020 for Perjeta growing to more than $5.4 billion in 2024. As we announced in February, Roche's BLA filing in the U.S. is accepted by the FDA and assigned an action date of October 18 2020. Roche expects the launch of this drug in the U.S. this year.
Regulatory submissions have also been completed in the EU and we expect that following a positive CHMP opinion approval would occur in 2021. On its most recent quarterly call, Roche indicated that it sees the SC, Perjeta, Herceptin combination utilizing enhanced technology as an offering, an advance and an advantage for the strained healthcare system. And in the past has also alluded to the fact that the combined product may offer some interesting pricing flexibility in the very competitive breast cancer segments.
I’ll turn now to Slide 7. Illustrated on this slide are the currently commercialized products that are approved or in development with ENHANZE. These are eight very successful products. We now have multiple examples to support that these carry a low risk of development with ENHANZE. When a product is already approved, the pathway to approval with ENHANZE has been a non-inferiority PK study to identify the dose, and then usually a Phase 3 study that focuses on demonstrating non-inferiority of the selected PK and efficacy endpoints. To date, all approved products that have had a successful Phase 1 and moved to Phase 3 have been approved.
Now excitingly, based on FDA feedback, many of our current partners are discussing leaner development programs designed to gain a full set of labeled indications for the IV without the need to do a separate control clinical trial for each indication. This faster development time allows earlier access for more patients to an SC formulation potentially. And the breadth of label that was just granted to DARZALEX FASPRO utilizing ENHANZE certainly provides encouraging evidence of this development strategy.
I’ll move now to Slide 8 and to our currently commercialized products. Roche continues with its global commercialization of products utilizing our ENHANZE technology, MabThera, RITUXAN HYCELA, and subcutaneous Herceptin with ENHANZE. Although royalty revenues from these products are anticipated to decline modestly this year as a result of the ongoing impact from biosimilars, Roche recently commented that it has seen an increased level of interest from physicians in subcutaneous Herceptin. While it’s too early to call this a trend, it is certainly worth noting in the current environment for reducing the amount of time and the presence of others is desired.
Moving now to our development products. On Slide 9, you can see a summary of the pipeline products that are being developed utilizing ENHANZE. Based on the most current information we have from our partners, our target for nine new trial starts in 2020 is unchanged. The Phase 2 trial we projected has been accomplished and I’ll detail this in a moment, and we continue to project three Phase 3 trial starts and five new Phase 1 starts in 2020.
Let me just provide two program updates. With regards to the Phase 2 start just mentioned, argenx recently initiated their Phase 2 study of efgartigimod, utilizing our ENHANZE technology in CIDP patients that they had announced in December of 2019. This study has an innovative design intended to result in a faster time to a go/no-go decision for advancement to a potential Phase 3 study. In addition, argenx is evaluating a bridging strategy for efgartigimod with ENHANZE in myasthenia gravis.
Moving down to Alexion, they recently informed us that they no longer plan to evaluate ALXN1810 in the renal basket study as they had announced in January of this year. There was no milestone associated with this study.
Moving now to Slide 10. The progress of our ENHANZE portfolio is projected to drive the strong growth in milestone revenues between now and the end of 2022. Based on the latest information we have from partners, we continue to project cumulative milestone revenues in the next three years of $350 million to $450 million. This growth in projected milestone revenues has been driven by the larger milestone payments associated with new target approvals and the increase in the number of products advancing to later-stage development, many of which are also associated with larger milestones. And this near-term millstone revenue proceeds royalty revenues and is an important and strong indicator of future royalty revenue potential, which we project to be approximately $1 billion in 2027 based on a non-risk adjusted revenue projections for programs currently in or planning to be in development.
Let me turn now to Slide 11, an overview of our approach, the capital return. As a reminder, our first priority is to drive the growth of our ENHANZE business by maximizing the value of our current collaborations and working to sign new collaboration partners. With a strong free cash flow, our next priority is returning capital to investors via share repurchases. Elaine will discuss the details of our recent share repurchase activities in just a moment. And in addition to our commitment to capital return, we will evaluate the potential for new technology platform expansion through acquisitions with the goal of accelerating our long-term revenue growth. In evaluating this, we are seeking an approach at where there is high growth and high margin similar to our ENHANZE business.
Now with that update, I’m very pleased now to turn the call over to Elaine for a discussion of the first quarter financial results.
Thank you, Helen. And I could not be more excited to join Halozyme during such a thrilling time for the company. I’ll start by turning to Slide 12 for a review of our first quarter revenues.
Total revenue for the first quarter was $25.4 million compared to $56.9 million in the prior year period. As a reminder, the first quarter of 2019 reflected the signing of a new collaboration agreement with argenx that resulted in a $30 million upfront payment.
Royalty revenue for the quarter was $16.8 million, a decrease of 6% which is consistent with our stated expectations coming into the year, driven by ongoing pricing pressures in the face of biosimilars. Product sales of $8.1 million in the quarter compared to $8.4 million in the prior period. We continue to expect that product sales of API will fluctuate in future periods based on the needs of our collaboration partners. Collaboration revenue in the quarter totaled $0.4 million compared with $30.6 a year ago with the difference attributable to the signing of the argenx deal that I mentioned a moment ago.
On Slide 13, you’ll find a more detailed breakdown of our first quarter P&L. I’ll begin with total operating expenses, which were $28.6 million in the first quarter, down from $54 million in the prior year period. The overall decrease in total operating expenses resulted from our shift in strategic focus to the company’s ENHANZE drug delivery technology in November of last year and the related restructuring which has largely been completed.
Cost of product sales were $5.8 million, up from $4.6 million. And research and development expenses of $10.2 million decreased from $31.3 million in the prior year period, decreasing 67% as a result of the fact that we halted our PEGPH20 oncology drug development activities in November of last year.
SG&A expenses were $12.6 million, down from $18 million in the prior year, primarily due to the reduction in force and discontinuation of our PEGPH20 related launch expenses that were part of the restructuring initiated in November last year.
Net loss for the quarter was $6.1 million or $0.04 per share compared to net income of $1.8 million or $0.01 per share in the first quarter of 2019. Cash, cash equivalents and marketable securities were $368.2 million at March 31, 2020 compared to $421.3 million at December 31, 2019, and the decrease reflects the impacts from our operating loss and share repurchase activities during the first quarter of 2020.
Now I’ll turn to Slide 14, for a discussion of our 2020 financial guidance. We continue to monitor the impact of the COVID-19 pandemic on our business and receive updates from our partners and suppliers as to their plans and timeline. And based on that latest information and our planned expenditures for the year, our guidance for 2020 remains unchanged from the guidance that we first provided for the year on January 14.
We continue to expect total revenues to be in the range of $230 million to $245 million and earnings per share is expected to be in the range of $0.60 to $0.75. In addition, we continue to forecast our first quarter of sustainable profitability will occur in the second quarter of this year. With respect to our expense structure, we’ll continue to watch operating expenses closely and we expect to achieve annualized operating expenses, excluding cost of goods sold and the range of $65 million to $75 million by the fourth quarter with the expectation that will lead towards the higher end of the range.
I’ll now detail our recent share repurchase activity. So in summary, we’ve completed $251.6 million of share repurchases to date, leaving $298.4 million available under the $550 million three-year share repurchase program that was authorized by our Board of Directors in November 2019.
In January 2020, we announced our plan to repurchase up to $150 million worth of shares in the year. And of this, we repurchased 3.2 million shares during the first quarter at a weighted average price of $16.15 per share worth approximately $51.6 million. We planned to repurchase up to an additional $98 million worth of shares during 2020, tending market conditions and other factors.
And with that, I’ll turn the call back to Helen.
Thanks very much, Elaine. In these uncertain times, I’m very pleased to say Halozyme remains in a strong financial position as a company focused solely on ENHANZE, with profitability on the horizon and a demonstrated commitment to maximize value for our shareholders by returning capital to our investors. The recent announcement of FDA approval for DARZALEX FASPRO was a momentous event for the company and there are many additional exciting events that anticipated in the remainder of 2020 as is shown on Slide 15.
Firstly, of course is the expected U.S. launch of DARZALEX FASPRO, which will result in a milestone payment to Halozyme. This event is a key driver of our expectation that we will report our first quarter of sustainable profitability for the second quarter of 2020, the current quarter. With Janssen receipt of a positive CHMP opinion, we anticipate marketing approval in Europe for subcutaneous DARZALEX utilizing ENHANZE around mid-year. And with an FDA action date of October 18, 2020, we anticipate approval and launch of the fixed-dose combination of Perjeta and Herceptin in the U.S. later this year. And we can expect continued momentum in the clinic as I detailed for our partner programs utilizing ENHANZE, leading to three new Phase 3 trial starts and five new Phase 1 trial starts.
With key milestones on the horizon and a clear path towards sustainable growth in revenues, earnings and cash flow, Halozyme is in a strong position to deliver additional value to our shareholders. And none of this would be possible without the strong talent at Halozyme team, and as ever I’d like to end by thanking everyone on the team for your tremendous efforts and the strong results for the first quarter.
We’d be delighted to take your questions. Operator, please would you open the call?
[Operator Instructions] Your first question comes from the line of Do Kim of BMO Capital Markets. Your line is open.
Thank you. Good afternoon and thanks for taking my question. My first question for the approval of DARZALEX FASPRO, do you know why Janssen did not pursue the combination with pomalidomide? Did they see that as not a big enough opportunity? And according to the CHMP positive opinion, it doesn’t include all current DARZALEX indications. Does that mean that we should expect seven out of seven indications for the EU approval?
All right, thanks, Do. With regard to pomalidomide, the filing which was based on the COLUMBA and PLEIADES study did not include any data looking at subcu daratumumab with pomalidomide. And so I think that is the key reason that the approval was not granted. Now, if you go onto clinicaltrials.gov, you will see there is a subcu daratumumab study ongoing with pomalidomide that has a potential readout date of mid-2021. So I think it’s not a question of it never getting approved, it just it will await that data.
With regard to the CHMP opinion, I think the key difference is that in Europe, they have a slightly different set of indications in Europe. They do have one transplant eligible indication, which is different from the U.S. and they do not have the pomalidomide indication. So it is a full set, but it’s not a matching set to the seven U.S. indications, but I believe it might be six. But if you compare the labeled indications though, you’ll see the key differences. Europe has transplant eligible, but pomalidomide is not approved in Europe for use with daratumumab from my recollection.
Okay, great. Thank you. And with the Board approval of DARZALEX to include all those indications, did you consider an opportunity to revise guidance upward? Would there be a possibility and an upside to the royalties, and instead of being slightly down to being flat or even up?
Yes. We always want to just see how the launch goes. There’s always the mechanics that need to be in place though that will take several months as you know, to get the J code, the EMR, et cetera. So we have not updated our guidance on it, but we will obviously watch the trend. And once those particular things are in place, including certainty of reimbursement and the ability to order, we do believe there will be very robust update of daratumumab.
Great. Thank you for taking my questions.
Thank you.
Your next question comes from line of Jessica Fye [JPMorgan]. Your line is open.
Hey, guys. Good afternoon. Thanks for taking my questions. Just following up on the comments you made in prepared remarks about the slight shift in timelines as it relates to trial starts, I’m trying to think about your anticipated milestones this year. And I’m wondering if you can offer any color on the cadence of milestones over the course of 2020. I guess, at a minimum, should we have relatively low expectations for the milestones in the second quarter given COVID-19’s kind of pronounced impact this quarter?
So our milestones obviously are made up of the potential approvals as well as the clinical study starts, and in the second quarter with the expectation that Janssen is launching in the U.S., we already know we’re going to have a nice milestone related to that. But I would say that for the clinical study starts, they are spread over the second, third and fourth quarter, but perhaps more in the third and fourth quarter, so you would see more of those clinical study starts then. For the European approval of daratumumab, we expect that mid-year falling into the third quarter. So hopefully that gives you some cadence of between the two that are some commercial milestones more near-term with the clinical studies being a little bit more weighted towards the third and fourth quarter.
Okay, that makes sense. And then just within the kind of maintenance of your overall revenue guidance, did the mix of milestones versus royalties shift at all, i.e., are there any milestones that you’re kind of nudging into 2021, possibly being offset by royalties better than you previously modeled?
No. Overall, it pretty much was in line with our original plan for the year, Jess.
Great. Thank you.
Your next question comes from the line of Joe Catanzaro [Piper Sandler]. Your line is open.
Hey, guys. Thanks for taking my questions here. I just wanted to follow up on something you alluded to earlier. And I know you’ve previously spoken about the time it takes for underlying formularies to change, but for DARZALEX FASPRO, I wonder if there are any expectations of seeing formulary exceptions, especially in light of the current COVID environment. And I guess as a follow up to that, maybe anything you’ve seen with your legacy products and their use in the current environment and any potential read-through they may provide to early DARZALEX FASPRO usage? Thanks.
Yes, thanks, Joe. I haven’t seen Janssen make any comments about any expectations of different formulary expectations. But I do know that we are hearing in general that there is a desire to not have patients in infusion rooms for a long period of time. I think the most pertinent comment comes from Roche’s recent earnings call, where I think it was Bill Anderson commented on seeing an increase in demand of Herceptin SC for exactly that reason people not wanting to be in the infusion suite.
So while I have no specific information to support the hypothesis, Joe, I think the environment as you point out is one where subcu fits a number of the needs less time in hospital, less exposure to other patients. And hopefully the formularies and other groups are going to pay attention to that and operate in a way that supports a faster approval, but I have no data to support that at this point in time.
Okay, got it. Thanks. And then just I guess as a quick follow up, you mentioned you expect an update to DARZALEX, I guess, internal guidance and how you’re thinking about that. Is that something we should expect on your 2Q earnings call?
Let me clarify the statement. What I said Joe is we will watch and see where it goes. I’m very comfortable with the current guidance. If we see a different uptick, then we had models that is worthy of note that we obviously will update at this point in time. But I intended with my remarks to say we are comfortable with our trajectory and we will monitor and see if there’s a major deviation for that that would result in a need to change the guidance.
Okay, got it. That’s very clear. Thanks so much for taking my questions.
Thank you.
Your next question comes from the line of Jason Butler of JMP Securities. Your line is open.
Hi. Thanks for taking the questions. Just one on the potential new partnerships. Just the FDA or regulatory environment now potentially being more expedited for ENHANZE approvals. Does that in anyway impact your outlook for ongoing partnership activities either in terms of level of interest or the value that you think you can generate out of new deals?
Thanks, Jason. I would say that we had built a very strong slate of potential partners we were talking to even before the COVID-19 pandemic. But I do agree with you, there is definitely a number of incoming calls looking for SC and understanding would it be another way to deliver care. So it has caused a modest increase, but overall the dynamic we’re seeing was already very nicely in place. So hopefully that addresses your question.
Yes. And then just one on the 2027 royalty guidance. Just based on the updates through the quarter, any notable changes in the different components of products that build to that number? Or is that essentially everything largely in line with how you thought about it early in the year?
Yes, it’s largely in line, Jason. We are reflecting differences in clinical study timelines, probably more than changes in the products in or out of the portfolio. But pretty much a very similar picture to one we showed before with that potential in 2027 really being driven by the number of products that we project having in the clinic at that point in time and approved in that nice growth trajectory point.
Okay, great. Thanks for taking the questions.
Thank you.
Your next question comes from the line of Charles Duncan of Cantor Fitzgerald. Your line is open.
Hi, Helen and team. Thanks for taking my questions. I apologize if they’ve been asked, I’m juggling calls today. But I guess I’m wondering, first of all, when you think about the recent approval for subcutaneous DARZALEX, what are your assumptions of – what were your assumptions about the use of the drug? It seems like it was a broader label than what we had anticipated. I guess if you think about having to supply API, et cetera, what are the key levers here that you’re looking to pull in the near-term?
Yes, thanks, Charles. As we were getting ready for the potential approval, if you recall, we always talked about the expectation of approval in relapse/refractory, but did highlight the PLEIADES study and the fact that Janssen had filed that and linked it to the comments that had been made at the RITUXAN HYCELA ODAC to say perhaps they controlled study wouldn’t be needed. And so in our scenario planning, we planned for both. We plan for this broad label based on PLEIADES being added to COLUMBA.
And similarly for our API production, if you recall, 2019 was a year where we had a lot of API sales and we highlighted that that was both Janssen and Roche buying their API in anticipation of successful regulatory pathways and launches in 2020. So we’re feeling very good about both of those and they’re delighted obviously to get five of the seven indications in the U.S. and a CHMP opinion recommending approval of all of the indications in Europe. It really could not have turned out better in our review. So delighted with that.
Very good. And regarding that API, where’s it manufactured?
Our API is manufactured in the U.S. at two CDMOs that we have.
Okay. Okay, 100% and no disruption to the supply that you’ve experienced.
No, both of our CDMOs, we’re in regular contact with them and they’re considered essential businesses. They have got the materials and they are operating without an interruption related to COVID-19.
Super. And then I came in on the end of Jason’s question, so I’m not sure if this is what he’s asking. But I think he was – perhaps he was asking about new collaborations and I guess I’m wondering about existing collaborations. And then the potential use of Herceptin SC relative to the biosimilars, is there any new or different feedback that you’re getting from current collaborators or from the market that suggests that there’s greater appreciation of subcutaneous versus IV value add in this current environment?
Yes. I would say with regard to Herceptin SC, Roche did say on their last quarterly call that they had seen an increased interest in demand for Herceptin SC in particular physicians that wanting to order it for compassionate use but also commercially. So to support the point that SC fits today’s environment, I think that is very true. Over existing collaboration partners, we’re in constant dialogue with them about the potential to select and move new targets into the clinic. I can’t say I have noticed a increase in that, there is already such an active dialogue around that, Chaz, but that hasn’t really changed.
But I would expect if we just think about this, there already were challenges to receiving IV therapies in these infusion suites. We know capacity is constrained, we know there aren’t enough nurses and we know that the overtime required with some of the therapies to keep the infusion centers open in the evenings and weekends is a challenge. So I think COVID-19 just adds to what was already a market environment conducive to companies and physicians and patients considering SC very seriously as an alternate.
Okay, very good. Thank you for taking my questions.
Thank you.
Your next question comes from the line of Graig Suvannavejh of Goldman Sachs. Your line is open.
Yes, thank you. Congrats on the progress and thanks for taking my questions. I actually let me send my congratulations to Elaine on joining and congrats on the role and I want to wish you well and maybe I can ask you a couple of questions if you don't mind, maybe can you give us your perspective of what you've seen thus far since you've joined and maybe if you can give us a sense of what your like near-term and mid-term priorities are and maybe another question for you if I could.
In terms of BD opportunities, it's something that company has talked to as something that they would look at and maybe prioritize in a go forward basis. Can you maybe comment on, what kind of opportunities you're seeing out there and the transactability and current valuations and your comfort with what you're seeing out there. And then maybe my last question Helen for you, just in terms of the label that we saw for DARZALEX FASPRO and I think we've got a sense of what pricing is like, but could you give us your sense of, what you see as potential barriers or hurdles or challenges that might prevent a rapid adoption of FASPRO relative to the conversion from IV DARZALEX? Any color there in terms of how you're thinking about things based at least from a label and pricing would be helpful. Thanks so much.
Great, Elaine, you answer Graig’s first two questions first.
Great. Thanks, Graig for that message. I think first of all, what excites me the most about joining Halozyme is really the potential in ENHANZE and I know that Helen's highlighted some of these, but what impresses me is that we've got a commercially validated platform technology utilized in blockbuster products for some of the leading pharma biotech companies around the world. And we're early in the growth cycle of revenue and earnings being driven by ENHANZE and with that strong cash flow generation that we expect from the ENHANZE business, one of my priorities is clearly one of our priorities is clearly prioritizing return of capital to shareholders, consistent with what we communicated to the market.
With respect to BD opportunities or M&A opportunities, of course if we find an attractive M&A opportunity that give us, that could give us the ability to add another platform technology with attractive growth and margin characteristics like ENHANZE, we could certainly think about that. And there are certainly opportunities we think out there but we're in no rush to do so, given the strong growth profile that we expect at ENHANZE. Hopefully, that answers your question.
Thank you.
That's great, Elaine and Graig with regard to the DARZALEX label, yes. I just mentioned to Chaz that we're obviously delighted with how broad it is, five of the seven indications for the U.S. which covers we believe the majority of use of daratumumab today and the CHMP recommendation is actually all of the indications in Europe, so broad label, great place to start. With any launch you always want to make sure reimbursement is going to be in place and with the change in the U.S. now to get the J codes quarterly, we anticipate that will just take a short period of time to get in place.
And that together with the getting on the formularies, getting loaded in EMR orders is all just a logistical situation that takes a period of weeks to months to get in place. But then we anticipate robust uptake based on the value proposition of the daratumumab the three to five minutes and the lower reported rate of infusion related reactions, when we talk to physicians we get a very positive and strong response to that value proposition.
So the only barriers are I believe the reimbursement and just getting these issues in place, that will be a differential in the amount of reimbursement between subcu and IV, I don't know exactly how much that will be, but again you've got to think about the strength of the value proposition, the desire for doctors and patients to not be in infusion suites for multiple hours. The nursing shortage and all those other factors, I really don't see many barriers to a very robust uptake for daratumumab in the U.S. and also in Europe upon approval.
Great. Thank you so much both.
Thanks Graig.
Your next question comes from the line of Arlinda Lee of Canaccord. Your line is open.
Hey guys, congrats on the progress. I had a few questions maybe just to follow-up on some of the points that you mentioned earlier. I'm wondering what is gating on subcu DARA and Perjeta/Herceptin uptake, you mentioned formulary J codes. I'm more interested in if there is any logistical hindrances or things that might help by the current situation. And I'm also curious about whether visiting nurses can deliver these subcu treatments at home for the patients don’t even have to come in. And then secondly, I'm also wondering if there's any difference in antibody versus small molecule delivery in combination and whether you guys are in discussions with Gilead, for example, programs converting that to subcu?
All right. Thank you. So with regard to the initial questions, I hopefully heard my answer to Graig. Every injectable product launch has a certain sequence of things need to happen for it to be, don't just be able to freely right. It will be no different for daratumumab, and I expect it will go over weeks to months. It will be very nicely in place and will not be a hindrance to uptake. The label for DARZALEX FASPRO says it must be administered by a healthcare professional. That whether Janssen plans to have that done in the infusion suite or perhaps some support clinics who won’t visiting at nurses.
I'm afraid, I don't know. I don't see a preclusion for it in the label Arlinda but I don't know if that's going to be part of the plan of the launch, there'll be a question better asked of Janssen.
And with regard to COVID-19, we actually have initiated discussion with a number of companies with regard to the potential of ENHANZE to allow their drugs to be given subcutaneously, particularly in settings of prophylaxis or early disease treatments and all of those discussions at an early stage.
And so I'm really not in a position to say anything more about any of them at this time, but we do see particularly in those COVID-19 settings, the benefits of SC where you might want to have a large volume of people be able to be treated in a clinic or in a hospital, in a shorter period of time. It seems like SC would be the way to go, but early discussions and nothing, I can really say more than that at this time.
Thank you.
Your next question comes from the line of Jim Birchenough of Wells Fargo. Your line is open.
Hi guys, it's Joe on for Jim. Congrats on the progress and appreciate you taking the questions, two from us. Are there any updates you can provide on pending or planned IP filings for novel compositions around ENHANZE formulations for the pipeline? And maybe second, how you view the approval of DARZALEX FASPRO in the U.S. in terms of de-risking other filings in the U.S. like Perjeta/Herceptin as an example?
All right. With regard to IP filings, it's an important part of our strategy as you're aware that when we can get co-formulation patents, it provides additional exclusivity in generally has the impact on our royalty term all of extending the duration and also pushing it at the time to the step down. So it's something we very actively are working on with our partners. I do see line of sight to additional IP filings.
I can't say any more than that at this point in time but given the fact that these are possible based on the novelty that is identified, when ENHANZE is combined with another proprietary drug, we know there are multiple pathways to this. It could be PK data. It could be clinical data. It could be pharmacodynamic data. And so, Joe to answer your question, yes.
There are definitely see line of sight to additional co-formulation patents being filed. On the DARZALEX FASPRO de-risking, I think where we see the biggest excitement about what DARZALEX FASPRO granted was the ability to get a broad set of indications without doing large comparative clinical studies for each and every indication.
And as I mentioned, this is really something the FDA spoke about at the RITUXAN HYCELA ODAC where or HYCELA, Roche had done three separate 500 patient studies for the three indications and what the FDA said was in future that might not be needed. And so what the DARZALEX clearly demonstrates is the one large comparative studies done in the relapsed refractory population. But for all the other indications in the front and second line that was granted based on the PLEIADES Study which was a 250 patient study single arm.
And so I think what the extrapolation is the ability once you've demonstrated the non-inferiority of efficacy and PK, the FDA is going to allow for leaner development plans in circumstances where they feel as though the safety has been well demonstrated. And that is very exciting for us and obviously for our partners meaning smaller need for the size of clinical programs to get the broad label.
Great. Thanks so much, Helen.
Okay, thanks Joe.
[Operator Instructions] Your next question comes from the line of Joel Beatty of Citi. Your line is open.
Hi, thanks for taking the question. The question is about strategy for the company as you become cash flow positive this quarter, does that put any type of timeline on making a decision on next steps regarding either some type of acquisition or returning additional cash to shareholders or some other choice?
Okay, I think it’s a great one for Elaine to give her perspective on. Elaine?
Sure. Thanks for the question, Joel. So we're very excited about the multiple catalysts in addition to the recent approval of DARZALEX FASPRO and expected multiple catalysts, we anticipate to drive our earnings and cash flow over the near and long-term. We're anticipating continuing to prioritize return to capital to shareholders as you mentioned and consistent with what we've communicated to the market.
So we anticipate with purchasing up to the $150 million in share purchases in 2020 pending market conditions and other factors. We'll continue to evaluate our capital structure to ensure that we're well positioned. But we continue to be very confident in our long-term growth prospects and so we anticipate continuing to be in position to return capital to shareholders again pending market conditions and other factors.
Got it. And how much of those planned repurchases for 2020 have been done so far?
So we were able to purchase nearly $52 million earlier this year at an average price of $16.15 per share. And that's on top of the $200 million in share repurchases that we completed through the concurrent buyback in ASR prior to that.
Okay, thank you.
There are no further questions over the phone lines at this time. I’ll turn the call back over to the presenters.
That's terrific. Well we really appreciate everybody joining us for today's call. As you’ve heard, despite COVID-19, we're very proud of the progress our partners are making and especially of the continued strong work of the Halozyme team who transitioned so well to the different work environment that we have. Thank you so much for your attention. We look forward to updating you next quarter. Good bye now.
This concludes today's conference call. You may now disconnect.